[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424769":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":53,"centralContacts":57,"locations":65,"responsibleParty":86,"collaborators":10,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":10,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":10,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":10,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single group, open labelled observational study with no blinding.",null,"All study patients will be managed per routine clinical practice and institutional standard for the performed surgery.",[13,14,15,16,17,18,19,20],"Other: 1.Baseline Measurements Before Surgery","Other: 2.Intraoperative Anesthetic Management","Other: 3.Postoperative Analgesic Management","Other: 4.Postoperative NRS Pain Assessment","Other: 5.Postoperative Global Rating Scale (GRS) Pain Assessment","Other: 6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain","Other: 7.Postoperative Quality of Recovery Assessment","Other: 8.Other Postoperative Assessments",[22,26,29,33,37,41,45,49],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"1.Baseline Measurements Before Surgery","* Baseline demographic data\n* Baseline physiological variables (blood pressure, heart rate, respiratory rate, oxygen saturation)\n* Baseline investigations (hemoglobin, coagulation profile, serum electrolytes) if appropriate.\n* Preoperative pain state using NRS (0-10)\n* Preoperative functional state using the QoR-15 questionnaire\n* Pain expectation - patients will be asked preoperatively with the question \"In a scale from 0 to 10 (where 0 = no pain and 10 = worst pain imaginable), what do you consider is an acceptable pain score for your first (and second) day after surgery?... Two weeks after surgery?\"\n* Pain castastrophizing scale",[9],{"type":6,"name":27,"description":11,"armGroupLabels":28,"otherNames":10},"2.Intraoperative Anesthetic Management",[9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"3.Postoperative Analgesic Management","postoperative pain will be managed on the ward using a multimodal analgesic regimen as appropriate. This includes:\n\n1. acetaminophen 650 - 1,000 mg given orally every 6 hours around the clock\n2. NSAIDs e.g., celecoxib or other agents given orally around the clock per clinical guideline; omit if contraindicated or per surgeon's preference\n3. Opioids e.g., hydromorphone 1-2 mg or oxycodone 15-30 mg given orally every 1-2 hours as required by the patient per standard nurse administered analgesic protocol.\n4. In the event of severe pain refractory to the above treatments, the patient will be offered IV opioid e.g., intermittent doses of 0.2-0.4 mg hydromorphone IV every 10 minutes until pain becomes tolerable",[9],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"4.Postoperative NRS Pain Assessment","Pain assessment using NRS pain scores (0 = no pain and 10 = worst possible pain) will be performed by an independent research staff, starting immediately in the PACU and serially over the first 48 hours after surgery or until hospital discharge.",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"5.Postoperative Global Rating Scale (GRS) Pain Assessment","Also, the degree of pain relief after treatment is assessed using a subjective 15-point Global Rating Scale (GRS) as mentioned above (Background). This is performed at the same time of each NRS assessment and a minimum of twice daily",[9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain","During each NRS pain assessment before or after an analgesic intervention on POD 0, 1 and 2, the patient will also be asked this question- \"\"In your opinion, do you consider your current pain state satisfactory after your operation?\" Patients giving a positive response are considered having an acceptable pain state. The PASS is the 75th centile for the pain NRS score in those with a satisfactory pain state.",[9],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"7.Postoperative Quality of Recovery Assessment","The quality of recovery 15 questionnaire (QoR-15) to measure the dimension of quality of recovery will be administered once in the morning of POD 1 and POD 2. The MCID and PASS for QoR are determined in the same way as for NRS score. The final MCID value will be average of 4 values, 1 generated by the anchor based method and 3 generated by the distribution based method. The PASS for QoR is the 75th centile of the QoR-15 score in those patients who rated their recovery as good.",[9],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"8.Other Postoperative Assessments","Additionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)\u002F and respiratory depression will be assessed daily.",[9],[54],{"name":55,"affiliation":5,"role":56},"Anahi Perlas, MD, FRCPC","PRINCIPAL_INVESTIGATOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Jayanta Chowdhury, MBBS,MD","CONTACT","4166035800","2016","jayanta.chowdhury@uhn.ca",{"name":55,"role":60,"phone":10,"phoneExt":10,"email":10},[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Toronto Western Hopspital","RECRUITING","Toronto","Ontario","M5T2S8","Canada","CA",{"type":75,"coordinates":76},"Point",[77,78],-79.39864,43.70643,{"lat":78,"lon":77},[81,83,84],{"name":82,"role":60,"phone":61,"phoneExt":62,"email":63},"Jayanta Chowdhury, MBBS, MD",{"name":55,"role":60,"phone":10,"phoneExt":10,"email":10},{"name":85,"role":56,"phone":10,"phoneExt":10,"email":10},"Anahi Perlas, MD. FRCPC",{"type":87,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100424769","mcid-and-pass-for-acute-pain-and-quality-of-recovery-after-orthopedic-surgery-100424769",false,"NCT04811209","MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery","Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery","Inclusion Criteria:\n\n* Adult patients aged 18-80 years\n* ASA class I - III\n* Primary elective surgery\n* unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures:\n* unilateral total hip replacement\n* unilateral total knee replacement, and\n* spinal decompression + fusion involving ≥ 2 levels.\n* Hospital admission for ≥ 24 hours after the surgery\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Poor English comprehension\n* Psychiatric disorders e.g., dementia\n* Known allergies to morphine \u002F hydromorphone\n* Chronic substance abuse and use of recreational drugs\n* Any medical disorder that impairs accurate and objective completion of questionnaires","ALL","18 Years","80 Years",{"count":99,"type":100},300,"ESTIMATED","OBSERVATIONAL","This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.",[104],"Pain Management","2026-06-08",{"date":107,"type":108},"2026-06-10","ACTUAL",{"date":110,"type":108},"2021-06-21",{"date":112,"type":100},"2026-12-31",{"name":5,"class":6},1]